Cefteria^®

Cefteria is a preparation of Ceftibuten Dihydrate which is a semisynthetic oral cephalosporin. Ceftibuten exerts its bactericidal action by binding to essential target proteins of bacterial cell wall. This binding leads to inhibition of cell wall synthesis.

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Ceftibuten is indicated for the treatment of:
• Upper respiratory tract infections, including acute sinusitis, otitis media, pharyngitis, tonsillitis
and scarlet fever.
• Lower respiratory tract infections including acute bronchitis, acute exacerbations of chronic
bronchitis and acute pneumonia in patients appropriately considered for oral therapy (e.g.,
those with primary community acquired infections).
• Urinary tract infections: Both complicated and uncomplicated infections.
• Enteritis and gastroenteritis caused by Salmonella, Shigella or E. coli.

Route of administration: Ceftibuten should be taken in oral route.

As with other oral antibiotics, duration of treatment generally ranges from 5-10 days. For treatment of infections due to Streptococcus pyogenes, a therapeutic dose of ceftibuten should be administered for at least 10 days.

Adults: Recommended dose is 400 mg daily. Ceftibuten capsules may be taken without regard to meal time. For treatment in the following indications, this may be administered as 400 mg once daily: acute bacterial sinusitis, acute bronchitis, acute exacerbations of chronic bronchitis and complicated or uncomplicated urinary tract infections. For the treatment of community acquired pneumonia in patients in whom oral therapy is appropriate, the recommended dose is 200 mg every 12 hours.

Children: Recommended dose is 9 mg/kg/day (maximum of 400 mg daily) of the oral suspension. This may be administered as a single daily dose for treatment in the following indications: pharyngitis with or without tonsillitis, acute otitis media with effusion and complicated or uncomplicated urinary tract infections.

For the treatment of acute bacterial enteritis in children, the total daily dosage may be administered in 2 divided doses of 4.5 mg/kg every 12 hours. Children weighing > 45 kg or > 10 years may receive the recommended adult dose.

Ceftibuten suspension may be taken approximately 1 or 2 hours before or after meal time. Shake bottle well before measuring each dose.

Directions for preparation of suspension
Small bottle contains diluent and large bottle contains powder for suspension. Pour the diluent slowly into large bottle. Tighten the cap of large bottle and shake vigorously until it is completely mixed. Use measuring cup or dropper to consume reconstituted suspension. The reconstituted suspension is stable for 14 days when stored in the refrigerator at 2°C-8°C.
60 ml suspension: Add 40 ml diluent for 60 ml.
120 ml suspension: Add 80 ml diluent for 120 ml

1. Small bottle contains diluent (Purified water with methyl paraben & propyl paraben) and large bottle contains powder for suspension.
2. Pour the diluent completely into the large bottle.
3. Tighten the cap of the large bottle and shake the bottle vigorously until it is completely mixed.
4. Use the measuring cup or dropper to administer the reconstituted suspension.

Pregnancy: Ceftibuten is pregnancy category B drug. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Lactation: It is not known whether ceftibuten is excreted in human milk. Caution should be exercised when ceftibuten is administered to a nursing mother, if necessary breastfeeding must be discontinued.

Special precaution should be taken before use in penicillin allergic patients, patients with impaired renal function, history of complicated Gl disease particularly chronic colitis. As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If super infection occurs during therapy, appropriate measures should be taken. The dose of ceftibuten may require adjustment in patients with varying degrees of renal insufficiency, particularly in patients with creatinine clearance less than 50 ml/min or undergoing hemodialysis. Ceftibuten is readily dialyzable. Dialysis patients should be monitored carefully and administration of Ceftibuten should occur immediately following dialysis.

The most common side effects include aphasia, jaundice, melena, psychosis, serum sickness like reactions, stridor and toxic epidermal necrolysis.

Ceftibuten is contraindicated in patients with known history of hypersensitivity to ceftibuten or any other components of this product.

Drug interaction with medication: The effect of increased gastric pH on the bioavailability of ceftibuten was evaluated. A single dose of combination of aluminium hydroxide, magnesium hydroxide and simethicon did not affect the C_max or AUC of the ceftibuten. However, 150 mg of ranitidine q12h for 3 days increased the ceftibuten C_max by 23% and ceftibuten AUC by 16%.

Drug interaction with food and others: Not applicable.

Overdose of cephalosporin can cause cerebral irritation leading to convulsions. Ceftibuten is readily dialyzable and significant quantities can be removed from the circulation by a single hemodialysis session.

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Store in a cool (below 25°C) and dry place protected from light.

Cefteria 400 mg capsule: Each capsule contains Ceftibuten 400 mg as Dihydrate INN.
Cefteria powder for suspension: After reconstitution each 5 ml contains Ceftibuten 90 mg as Dihydrate INN.

Storage
Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.

Packing
Cefteria 400 mg capsule: Carton of 10 capsules in blister pack in sachet.
Cefteria powder for suspension: Bottles of 60 ml & 120 ml with diluent.